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  • 1
    Electronic Resource
    Electronic Resource
    Effect of two antacids on the bioavailability of paracetamol (1985)
    Springer
    European journal of clinical pharmacology 29 (1985), S. 251-253 
    Details
    ISSN: 1432-1041
    Keywords: paracetamol ; antacids ; acetaminophen ; bioavailability ; kinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The effect of two antacids on the bioavailability of paracetamol has been investigated in 12 young healthy volunteers. Following a random cross over design, each subject swallowed, on three separate occasions, one weak apart, 500 mg paracetamol alone, or together with two different aluminium hydroxide, magnesium hydroxide preparations (Dimalan and Maalox). Plasma paracetamol levels were measured by HPLC. The bioavailability of paracetamol was not altered by either antacid, but they both delayed the time to peak plasma concentration (0.85 h; 1.43 h; 1.25 h, without antacid, with Dimalan and with Maalox respectively). The peak plasma concentration was not affected by concurrent antacid administration.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00547432
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  • 2
    Electronic Resource
    Electronic Resource
    Effect of aluminum phosphate on the bioavailability of ranitidine (1987)
    Springer
    European journal of clinical pharmacology 32 (1987), S. 97-99 
    Details
    ISSN: 1432-1041
    Keywords: ranitidine ; aluminium phosphate ; antacids ; bioavailability ; drug interaction ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The effect of aluminum phosphate on the bioavailability of ranitidine has been investigated in 10 young, healthy volunteers. Following a random cross over design, each subject took at a 1 week interval 150 mg ranitidine alone or with 11 g aluminum phosphate. Plasma and urine ranitidine levels were measured by HPLC. The antacid reduced both the maximum plasma ranitidine concentration by 40% and the area under the curve by 30%. Elimination of ranitidine was not changed. The results indicate that aluminum phosphate significantly diminished the bioavailability of ranitidine.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00609966
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  • 3
    Electronic Resource
    Electronic Resource
    Comparison of 500 spontaneous and 500 published reports of adverse drug reactions (1990)
    Springer
    European journal of clinical pharmacology 39 (1990), S. 287-288 
    Details
    ISSN: 1432-1041
    Keywords: adverse drug reactions ; spontaneous report ; published report ; causality assessment ; diagnostic criteria
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The information and case quality of 500 spontaneous and 500 published adverse drug reaction (ADR) reports were compared, including a study of the most common criteria used in different causality assessment methods. The criteria were more often of positive value in the published reports. Nevertheless, spontaneous reports play an important role in the detection of new ADRs.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00315112
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  • 4
    Electronic Resource
    Electronic Resource
    Adverse drug reactions: physicians' opinions versus a causality assessment method (1994)
    Springer
    European journal of clinical pharmacology 46 (1994), S. 285-289 
    Details
    ISSN: 1432-1041
    Keywords: Adverse drug reaction ; causality assessment ; agreement
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Since spontaneous reporting of adverse drug reactions depends on the physician's opinion of the relationship between the drug and the adverse event, we compared physicians' opinions with the scores obtained by the causality assessment method used in France. During a 2 month period, all physicians who reported adverse drug reactions (ADRs) to our pharmacovigilance centre expressed their opinions on the causal link by means of visual analogue scales. ADR reports were then assessed with the French causality assessment method by a clinical pharmacologist who was blind to physicians' opinions. The assessment by both physicians and the standardized method was performed for 75 ADR cases involving 120 drugs. Physicians used a wide range of assessments, with a preponderance of extreme scores, resulting in a U-shaped distribution, while the standardized method gave generally low scores. Scores given by physicians were very high (causality considered very likely or likely) in 60% of cases and very low (causality considered unlikely or dubious/possible) in 32% of cases. Scores obtained using the causality assessment method were low (causality dubious/possible) in 89% of cases and causality considered likely in only 11 cases, essentially in cases with positive rechallenge. Complete agreement occurred in only 6% of cases. Adding complete agreement and minor discrepancies raised the percentage to 49%.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194392
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  • 5
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of famotidine in patients with cirrhosis and ascites (1992)
    Springer
    European journal of clinical pharmacology 43 (1992), S. 559-562 
    Details
    ISSN: 1432-1041
    Keywords: Famotidine, Cirrhosis ; pharmacokinetics, ascites
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The pharmacokinetics of famotidine has been investigated in ascitic cirrhotic patients. 10 decompensated cirrhotic patients were studied (9 m, 1 f), who had normal renal function, and six healthy control subjects (4 m, 2 f), matched for age, sex and weight. Each subject received on two occasions, at least four days apart, a single oral (40 mg) or intravenous dose (20 mg) of famotidine, at 21.00 h in a randomised manner. Serial blood samples were collected and famotidine in plasma was determined by a HPLC/UV method. Plasma data were subjected to non compartmental pharmacokinetic analysis. There were no statistically significant differences in pharmacokinetic parameters between the two groups after either the intravenous or oral administration of famotidine. The findings suggest that the dose of famotidine may not require any adjustment in ascitic patients without renal failure.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02285103
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  • 6
    Electronic Resource
    Electronic Resource
    European network for the case–population surveillance of rare diseases (Euronet). A prospective feasibility study (1998)
    Springer
    European journal of clinical pharmacology 53 (1998), S. 299-302 
    Details
    ISSN: 1432-1041
    Keywords: Key words Surveillance of rare disease ; European net work
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Euronet, a case-population surveillance scheme, aims to estimate the risk of certain rare conditions which are commonly iatrogenic, by comparing drug use amongst non-selective cases with overall drug use in the general population. Methods: The method is based on three provisos: (1) all incident cases (irrespective of suspected aetiology) should be ascertained and studied; (2) a full drug history should be obtained from cases by direct interview; and (3) drug-use data for the products of interest should be available for this population from which cases are chosen. The feasibility of this problem-oriented approach for the identification of new signals of adverse drug reactions and for risk estimation will be tested in relation to agranulocytosis, Stevens-Johnson syndrome and toxic epidermal necrolysis in four defined areas in Europe, totalling 19 × 106 inhabitants, with these latest two outcomes being studied in only three regions. The design, methods and main limitations of this case–population surveillance approach are described.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050382
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  • 7
    Electronic Resource
    Electronic Resource
    Effect of aluminium phosphate on the bioavailability of cimetidine and prednisolone (1984)
    Springer
    European journal of clinical pharmacology 26 (1984), S. 271-273 
    Details
    ISSN: 1432-1041
    Keywords: cimetidine ; prednisolone ; aluminium phosphate ; antacids ; bioavailability ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Ten fasting subjects received 200 mg cimetidine orally either with water or 11 g aluminium phosphate mixture in a randomized, single dose, two-way cross-over study. Blood samples were taken for 12 h and urine was collected for 24 h. Cimetidine in plasma and urine was analysed by HPLC. There were no significant differences between the treatments with respect to peak plasma concentration, time to peak plasma concentration, area under the plasma concentration-time curve, and urinary excretion. In 12 healthy subjects the absorption of prednisolone was investigated when given alone and together with 11 g aluminium phosphate. Blood samples were taken over 16 h and prednisolone in plasma was analysed by HPLC. There were no significant differences in the values of area under curve (AUC), Cmax and tmax. The results indicate that aluminium phosphate does not reduce the bioavailability of cimetidine and prednisolone.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00630299
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  • 8
    Electronic Resource
    Electronic Resource
    Under-reporting of adverse drug reactions Estimate based on a spontaneous reporting scheme and a sentinel system (1998)
    Springer
    European journal of clinical pharmacology 54 (1998), S. 483-488 
    Details
    ISSN: 1432-1041
    Keywords: Key words Adverse drug reactions ; Pharmacovigilance
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Spontaneous reporting is the most common method used in pharmacovigilance and the best one to generate signals on new or rare adverse drug reactions (ADRs). Under-reporting is a major drawback of this system. The objective of this study was to quantify the extent of under-reporting in general practice and to assess the factors which influence it. Methods: Details of ADRs collected through a short intensive survey were compared with primary care spontaneous reports received by the Castilla y Leon Regional Pharmacovigilance Centre during a 12-month reference period. The survey was undertaken by a random sample of 146 general practitioners (GPs), providing care to 149 487 people. The pharmacovigilance centre received reports concerning the whole regional population (2.5 million) covered by primary health care. The under-reporting coefficient (U) was estimated as the ratio between the number of effects observed by physicians in the survey and those spontaneously reported to the pharmacovigilance centre. Results: The overall under-reporting rate was 1144 [95% confidence interval (CI): 928–1409]. Under-reporting was greater for psychiatric (2119; 945–4752) and gastrointestinal (1946; 1424–2659) disorders. Severe effects were more reported (U=605; 151–2431) than moderate (863; 473–1575) and mild (1209; 973–1503) ones. The under-reporting rate was lower for drugs recently marketed (706; 406–1230) and slightly lower for unlabelled effects (1031; 641–1657). Conclusion: The under-reporting rate of ADRs is considerable, though not homogeneous for the different cases. This should be taken into account when comparing adverse effects (AEs) for different drugs. Under-reporting seems to be positively selective, as it involves mainly the less severe and better-known effects, preserving the value of spontaneous reporting for signal detection.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050498
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  • 9
    Electronic Resource
    Electronic Resource
    Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability (2000)
    Springer
    European journal of clinical pharmacology 56 (2000), S. 181-186 
    Details
    ISSN: 1432-1041
    Keywords: Key words Adverse drug reactions ; Hospital ; Costs
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Adverse drug reactions (ADRs) are a major cause of hospital admission and in-hospital morbidity. Departments of internal medicine are at the forefront of this problem. To increase the knowledge base, we did a study of the frequency, hazard function, avoidability, and cost of ADRs as a cause for admission in internal medicine, or when occurring after admission. Methods: This prospective cohort study was based on all admissions to an internal medicine unit over a 4-month period. Patients were intensively followed in order to assess any ADR occurring during the hospital stay. Causality, direct costs, and preventability were assessed. Results: Of 444 admissions (2569 patient-days), 156 ADRs occurred in 116 patients (26.1% of all admissions); 95 (21.4%) of these had ADRs at admission, which were the reason for admission in 32 (7.2%). Twenty-one patients (4.7%) presented with 26 ADRs during hospitalization. The in-hospital ADR incidence rate was 10.1 per 1000 patient-days. The cost of ADRs leading to hospitalization was estimated at Euro 11,357 per hospital bed per year. Eighty percent of ADRs could be considered preventable. Conclusion: ADRs in hospitalized patients are common and often preventable. Since most ADRs occurred before admission, prevention strategies should preferentially target primary health care providers.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050738
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